NDA 208715

SANDOZ INC

FDA Drug Application

Application #208715

Documents

• Label: 2023-01-06
• Letter: 2023-01-06

Application Sponsors

NDA 208715

SANDOZ INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	SOLUTION;INTRAVENOUS	45MG/4.5ML (10MG/ML)	1	CABAZITAXEL	CABAZITAXEL
002	INJECTABLE;INJECTION	60MG/6ML	0	CABAZITAXEL INJECTION	CABAZITAXEL

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

TA

2017-03-02

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208715
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CABAZITAXEL INJECTION","activeIngredients":"CABAZITAXEL","strength":"45MG\/4.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"CABAZITAXEL INJECTION","activeIngredients":"CABAZITAXEL","strength":"60MG\/6ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/02\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-03-02
        )

)